H & T Seafood, Inc. – FDA Warning Letter, Jan 15, 2015

On February 11, 2015, the FDA issued a Warning Letter to H & T Seafood, Inc. following an inspection from January 13-15, 2015. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) for their seafood importer establishment.

Specifically, the firm failed to comply with 21 CFR 123.12(a)(2)(i) by not having product specifications for frozen Tilapia Fillets from (b)(4) to ensure they are not injurious to health or processed under insanitary conditions. Additionally, the firm did not implement an affirmative step as required by 21 CFR 123.12(a)(2)(ii) to ensure imported frozen Tilapia Fillets from (b)(4) and frozen Chum Salmon from (b)(4) were processed in accordance with seafood HACCP regulations.

These violations render the frozen Tilapia Fillets and frozen Chum Salmon Portions adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)). The FDA warned that failure to promptly correct these issues could lead to refusal of admission of imported products, detention without physical examination, seizure, and/or injunction. H & T Seafood, Inc